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Zenith's BET Inhibitor ZEN-3694 is Currently Being Evaluated in Multiple Oncology Clinical Trials

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Message: time lines and yet to come...

Zenith is much more early stage relative to Resverlogix, so the "time lines and yet to come..." is relatively short for Zenith.

The single-agent ZEN-3694 trial entitled "A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer" is completed. 

The Phase 1 portion of the ZEN-3694/enzalutamide combo trial entitled "A Study of ZEN003694 in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer" is probably completed, or at the very least in the wrap up stages. It was unclear from the recent news release if the Phase 1 is still ongoing.

The news release stated "Clinical data to date show that ZEN-3694 is active, safe, and well differentiated and will be presented at an upcoming scientific meeting." So Phase 1 results from either the single agent trial, or potentially both the single agent and combo trial may be presented soon. I'm not certain, but my hunch is that they will be presenting this at the November EORTC-NCI-AACR SYMPOSIUM. I look forward to a more comprehensive presentation of the ZEN-3694 mCRPC at the AGM Corporate update, or whatever scientific meeting is chosen.

As stated in the recent news release, this combo trial has moved on to the Phase 2 stage (same ClincialTrials.gov listing as the Phase 1 combo trial). I don't think the current ClinicalTrials.gov page is up to date though, since the enrollment only lists 58 patients and estimated completion as June 2019. The slide deck from March 2018 indicated ~150 patient with completion stretching into 2020. The more recent slide deck from June 2018 didn't have any info on # of patients or timeline for the Phase 2. We'll have to wait for the AGM/Corporate update next month for clarification on this.

No other trials are listed for Zenith on ClinicalTrials.gov or listed in the June 2018 slide deck. However, several "potential" trials were listed on slide 15 in the March 2018 slide deck including:

  • ZEN-3694/abiraterone combo trial for mCRPC
  • Phase 1b/2a: ZEN-3694 + PARPi in HRD+/ HRD- patients(breast, CRPC, ovarian), DE and DC
  • Ph 1b/2a : ZEN-3694 +fulvestrant in ER+ breast cancer, patients progressing on CDK 4/6 inh./ER modulator in Renal/Melanoma/HNSCC/NSCLC/Bladder, others, patients progressing on PD1/PD-L1 Mab

Now those slides/proposed trials were from 5 months ago. Plans change. No official trial was listed on ClinicalTrials.gov and no concrete statements were made regarding timelines of these trials. So unlike Resverlogix, who made more concrete statements about planned trials, I am not holding Zenith to what was listed on slide 15 from 5 months ago. But at the AGM, I do hope DM clarifies which program(s) will be advancing next, when the trial will start, and how they will be funded. 

For the proposed equity private placement referenced in the recent news release, it states "The Company also announced that it intends to complete an equity private placement of up to 10 million common shares (the “Offering”). The net proceeds of the Offering will be used to fund research and development activities, general and administrative expenses, working capital and other general corporate purposes. Investment will be restricted to qualified Investors only on a first subscribed basis."

How much of the "up to 10 million common shares" have been offered? How much $ has been brought in from this offering so far? Is the private placement still ongoing? Will it be used for anything beyong Phase 2 combo trial for mCRPC?

I would love for Zenith to comment on competitors. Lots of pan-BET inhibitors in trial for various cancers. In June slide deck, they listed GSK and Gilead as BET inhibitor/prostate cancer competitors. Is ZEN-3694 superior to these, or are they all successful and racing to the prize?

Update on plan to sell or publicly list ZEL and/or ZCC? Is there a plan to raise funds for ZEL clinical programs without continuing to dilute ZCC and effectively dilute the Resverlogix royalty preferred shares?

That's all I've got. Others please reply and add on your additions to the "timelines and yet to come...."

BearDownAZ

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